Kornimate/medical-research-clean huggingface dataset:
prostate boost irradiation with stereotactic body rt (sbrt)

Conditions: Prostate Cancer

Summary: a randomized controlled open-label trial in patients with high risk prostate cancer. eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (sbrt) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. prostate radiotherapy boost will be administered after standard pelvic radiotherapy. subjects will be followed for 24 months post radiation treatment for quality of life assessment and toxicity.

in this study we investigate stereotactic body radiotherapy (sbrt) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (prca) treated with androgen deprivation therapy (adt). one hundred patients with localized high risk prca will receive adt for a total of 3 years. three months after initiation of adt all patients will receive pelvic (lymph node and prostate) treatment of 45gy in 25 fractions (5 days per week). then patients will be randomized to receive either the conventional radiotherapy (crt) of 33 - 35 gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or sbrt boost treatment of 19.5 - 21 gy in three fractions (1 treatment per week - over 22days) (experimental arm). sbrt boost treatment will be delivered with either cyberknife or vmat technique.

Eligibility criteria:
inclusion criteria: * histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage t3 or higher and/or gleason score 8 or higher and/or initial psa level above 20;) * no radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and ct-scan of the abdomen and pelvis) or incidental findings (localized n0, m0 disease) * patient is able to complete the quality of life questionnaires in english. * informed consent obtained exclusion criteria: * • histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date; * previous treatment for carcinoma of the prostate (other than biopsy or turp), including bilateral orchiectomy; * patients previously on more than twelve weeks of hormone therapy for their prca; * past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years; * contraindications to placement of gold seeds for daily prostate localization; * previous pelvic rt and/or significant pelvic surgery; * severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist) * previous hip replacement * psa over 50 * ipss 20 or higher * trus-based prostate * volume of \> 80 cc

Keywords: stereotactic body radiotherapy (sbrt) conventional radiotherapy (crt) high risk prostate cancer quality of life (qol) the expanded prostate cancer index composite (epic-26) international prostate symptom score (ipss)
novel testing procedures

Conditions: Immunodeficiencies

Summary: the purpose of this study is to evaluate a novel screening test to detect patients with primary immunodeficiencies(pids). the investigators plan to use information gained from this study in order to advance the field of clinical immunology, thus improving the diagnosis, treatment, and well-being of future patients. the purpose of this study is to determine if this screening test is able to detect patients with immune problems, and the investigators will test patients with known pids to determine if the test is accurate the investigators hypothesize that detecting serum immunoglobulins from dried blood spots will be effective in detecting patients with known primary immunodeficiencies. if our hypothesis is confirmed, it opens the possibility of using point of care testing to screen for primary immune deficiencies. age of study subjects will range from 1 year to 80 years of age, and will be recruited form the immunodeficiency clinic at the medical college of wisconsin/children's hospital of wisconsin (mcw/chw). any subject having testing done to evaluate the immune system is eligible for this study. this will include patients with known pids as well as patients evaluated for a suspected immunodeficiency. it is anticipated that 150 subjects will be analyzed over a two year period.

after consent is obtained, blood will be obtained. the total amount of blood to drawn in one day will not exceed 1.5 ml (1/3 tsp) per pound of body weight. all samples will be collected at the same time as routine blood draws as ordered by your physician. subject samples will be de-identified by the principal investigator (pi) and given a serial number. the pi will retain a secured log of the serial numbers and basic identifiers (name, date of birth (dob0, sex, preliminary diagnosis, and test results), and the subject samples will be stored in a secured freezer. only the pi will have access to the secured log book. all study test results will be kept on compact discs, or similar computer storage devices, in a secured area that will only be accessible by the pi. study test results will not kept on computers accessible by other individuals. the samples will not be sold to any third party. the results of this research will not be conveyed to any third party. if the subject withdraws or is withdrawn from the study all identifiable biological samples from that subject will be discarded. the sample will not be available for any other type of testing outside of this study.

Eligibility criteria:
inclusion criteria: * any subject having testing done to evaluate the immune system is eligible for this study. exclusion criteria: * inability or unwillingness on the part of the parents or individual to provide clinical or family history, or refusal to allow blood sampling.

Keywords: immunodeficiency
developing a home telehealth program to manage pressure ulcers in sci/d

Conditions: Spinal Cord Injury

Summary: the veteran's health administration (vha) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (dmps). no such dmps exist for the community dwelling spinal cord injury/disorders (sci/d) population. our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with sci/d at high risk of developing pressure ulcers (prus).

background: vha is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (dmps). no such dmps exist for the community dwelling spinal cord injury/disorders (sci/d) population. our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with sci/d at high risk of developing pressure ulcers (prus). objectives: the goal of the study was to complete activities necessary in preparation for implementing a home telehealth program to manage veterans with sci/d at risk of developing prus. specifically this rapid response project (rrp) included: 1) convening an expert panel to validate pressure ulcer (pru) pru dmp items; 2) developing a standardized protocol that specified how the nurse care coordinator who would manage patients who develop open skin wounds across the hub and spoke system of care; 3) assessing individual telehealth dmp items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) developing an instrument to assess staff satisfaction with this method of patient management. methods: a convenience sample of veterans about to be discharged home from the cleveland sci/d inpatient unit were asked to participate in the study. this included patients living close to the hub and those referred from spoke sites. subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period. status: the project team is conducting ongoing analysis of the data to develop publications.

Eligibility criteria:
inclusion criteria: - veterans admitted to cleveland va sci/d unit or treated in the outpatient clinic exclusion criteria: * no phone * cognitive impairment * hearing impairment

Keywords: pressure ulcer telemedicine
"twelve-week study of the safety and efficacy of jzp-110 in the treatment of excessive sleepiness in osa"

Conditions: Obstructive Sleep Apnea

Summary: this trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of jzp-110 in the treatment of excessive sleepiness in adult subjects with osa.


Eligibility criteria:
major inclusion criteria: 1. male or female between 18 and 75 years of age, inclusive 2. diagnosis of osa according to icsd-3 criteria 3. body mass index from 18 to \<45 kg/m2 4. consent to use a medically acceptable method of contraception 5. willing and able to provide written informed consent major exclusion criteria: 1. female subjects who are pregnant, nursing, or lactating 2. any other clinically relevant medical, behavioral, or psychiatric disorder other than osa that is associated with excessive sleepiness 3. history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to dsm-5 criteria 4. history or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, pk assessments, or the ability of the subject to complete the trial per the judgment of the investigator. 5. history of bariatric surgery within the past year or a history of any gastric bypass procedure 6. presence or history of significant cardiovascular disease 7. use of any over-the-counter (otc) or prescription medications that could affect the evaluation of excessive sleepiness 8. received an investigational drug in the past 30 days or five half-lives 9. previous exposure to or participation in a clinical trial of jzp-110 (adx-n05, r228060, or ykp10a) 10. history of phenylketonuria (pku) or history of hypersensitivity to phenylalanine-derived products
influence of probenecid and quinine on the pharmacokinetics of azidothymidine

Conditions: HIV Infections

Summary: part i studies the effect of quinine on how zidovudine (azt) is used by the body and eliminated through the kidneys in hiv infected patients. part ii studies the effect of probenecid and quinine on the same aspects. because azt leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. probenecid and quinine may slow down the rate at which azt leaves the body. therefore, taking these drugs along with azt may reduce the amount of azt needed for treatment.

because azt leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. probenecid and quinine may slow down the rate at which azt leaves the body. therefore, taking these drugs along with azt may reduce the amount of azt needed for treatment. in part i, four patients who are now receiving azt at the usual dose take part in pharmacokinetic studies (how much of the drug enters the blood stream, what happens to the drug in the body, and how it leaves the body) of azt defined after a dose while at steady state and then again after a new steady state has been reached following the addition of quinine sulfate. part ii studies the pharmacokinetics of azt in eight patients receiving azt at 1 of 2 doses and then at the lower dose of azt plus probenecid with or without quinine.

Eligibility criteria:
inclusion criteria patients must: * have symptomatic hiv infection. * be taking zidovudine (azt), 100 or 200 mg, 5 or 6 x/day. allowed: * history of pneumocystis carinii pneumonia (pcp). * advanced aids related complex (arc). * hiv antibody positive with an absolute cd4 lymphocyte count of \< 200 cells/mm3 before study entry. exclusion criteria co-existing condition: patients with any of the following conditions are excluded: * glucose-6-phosphate dehydrogenase deficiency. * allergy to sulfa drugs, probenecid, or quinine. concurrent medication: excluded: - other drugs that might influence the metabolism or renal excretion of zidovudine (azt).

Keywords: quinine probenecid drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine
glucose control in severely burned patients

Conditions: Burns

Summary: the central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. the investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.


Eligibility criteria:
inclusion criteria: * between 18 and 90 years of age * \>20% tbsa * admitted to the burn unit within 120 hours following burn * at least 1 surgical intervention necessary exclusion criteria: * death upon admission * decision not to treat due to burn injury severity * presence of anoxic brain injury that is not expected to result in complete recovery * known history of aids, arc, hiv, hepatitis b-e * history of cancer within 5 years of malignancy currently under treatment * inability to obtain informed consent * previous or existing renal dysfunction, liver disease, or hepatic dysfunction * pre-existing type i diabetes mellitus * pregnancy * allergy to metformin

Keywords: thermal injury chemical burn flame burn
prospective, multicenter observational study evaluating the long term safety of the custombone implant

Conditions: Surgery

Summary: a prospective, multicenter observational study evaluating the long term safety in terms of explantation rate and number of infections of the custom-made bioceramic implant custombone™ the patients will be included as soon as they are implanted and follow-up for 2 years. it is observational so no specific exam is planned. the explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).


Eligibility criteria:
inclusion criteria: * patient planning to have a cranioplasty and be implanted with the custombone™ medical device * patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter exclusion criteria: - patient who does not accept to take part in the study after being informed

Keywords: cranial prosthesis
trial with humax-cd4 in participants with rheumatoid arthritis (ra) failing treatment with methotrexate (mtx) and a tnf-alpha blocker

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether humax-cd4 is effective in the treatment of active ra in participants who have failed treatment with mtx and at least one tnf-alpha blocking agent.

this is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of humax-cd4 in the treatment of participants with active ra who have failed treatment with mtx and at least one tnf-alpha blocking agent. participants are randomized to receive one of two doses of humax-cd4 or placebo. the drug will be administered as a subcutaneous infusion (given just under the skin), more often in the beginning and then followed by a maintenance dose. there is a 4 week follow up period, and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start. the trial lasts about 28 weeks in all.

Eligibility criteria:
inclusion criteria: * a diagnosis of rheumatoid arthritis according to the american college of rheumatology 1987 revised criteria (acr) of at least 6 months duration. * active disease at the time of screening. * failure to tolerate mtx, or lack of efficacy after a minimum of 6 months treatment with mtx. exclusion criteria: * active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary sjögren's disease). * syndromes such as fibromyalgia which require chronic pain treatment. * most past or current cancers. * chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest, nasal or throat infections, tuberculosis, hepatitis b and c. * history of infected joint prosthesis within 5 years. * most active medical conditions such as heart disease, kidney disease, liver disease, blood diseases, hormonal disturbances, lung disease, psychiatric disease. * drug or alcohol abuse. * pregnant or breast-feeding women may not participate. women of childbearing potential must use either contraceptive pills or an intra-uterine device for the entire study period. note: other protocol defined inclusion and exclusion criteria may apply.
clinical trial to evaluate safety and efficacy of hyalospine® in lumbar laminectomy or laminotomy

Conditions: Degenerative Spinal Stenosis; Disk Herniation

Summary: the aim of this phase ii trial is to evaluate safety and efficacy of hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. the device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.


Eligibility criteria:
inclusion criteria: * scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation. * subjects who have failed conservative care for at least 6 weeks. exclusion criteria: * contraindication to mri * instrumented fusion
inhibin b/afc ratio for ovarian response

Conditions: IVF; Infertility, Female; Ovulation Disorder

Summary: ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (ivf). anti-müllerian hormone (amh), inhibin b, and antral follicle count (afc) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. ovarian responsiveness can also be assessed through the follicular output rate (fort), which evaluates the proportion of follicles that developed during stimulation by the ratio of pfc (preovulatory follicle count) to afc. fort highlights that some follicles do not respond to the fsh; therefore, this project proposes an endocrinological approach to this issue by relating afc to inhibin b and amh ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. the inhibin b/afc and amh/afc ratios correlated with fort and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness. a prospective cohort study will be conducted with patients of the insemine center for human reproduction. antral follicle count and amh measurement will be performed before ivf cycle initiation, and inhibin b measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. the primary outcomes will be the follicular output rate (fort) and the number of oocytes retrieved. secondary outcomes include the number of metaphase ii oocytes, oocyte quality, fertilization rate and embryo quality.


Eligibility criteria:
inclusion criteria: * first ivf; * without severe male factor involved. exclusion criteria: * patients with endometrioma; * ovarian cyst; * amh \< 0.5 ng/ml; * increased serum tsh (thyroid-stimulating hormone) or prolactin levels; * endocrinopathies; * previous oophorectomy; * failure to visualize one of the ovaries on ultrasound.
impact of blood salvage therapy on outcomes after oncologic liver surgery

Conditions: Liver Neoplasms

Summary: a before and after trial comparing the systematic use of blood salvage therapy with leucocyte filter during oncologic liver resections. recurrence, survival, allogenic transfusion rates and surgical outcomes are compared with a representative historic cohort.

blood salvage therapy in oncologic liver surgery is seldom used based on unproven concerns about the safety of the technique regarding potential cancer dissemination or recurrence. nevertheless, the technique has proven advantages in other surgical settings regarding the allogenic transfusion outcomes. allogenic blood transfusion has been scientifically proven to worsen prognosis in oncologic surgery. this study compares a cohort of patients systematically exposed the blood salvage therapy to one comparable cohort without the therapy and outcomes regarding transfusion rates, post-operative hb measurement, recurrence, overall survival, and post-operative adverse events.

Eligibility criteria:
inclusion criteria: * adult oncologic liver surgery scheduled in our institution exclusion criteria: * condition precluding consent for trial pregnancy

Keywords: blood salvage therapy oncologic liver surgery
effect of hyaluronic acid on tissue healing after removal of impacted mandibular third molars (lm3)

Conditions: Tooth, Impacted

Summary: hyaluronic acid (hy) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. after the application of hy, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. the removal of a mandibular wisdom tooth (lm3) often leads to remaining residual defects with increased probing depths distal to the second molar. to date, the influence of hy on periodontal healing of the distal aspect of the second molar after removal of the lm3 has not yet been investigated. accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of hy gel or hy gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the lm3 compared to the standard procedure (blood clot). a total of 102 patients with an impacted lm3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. in the hy test group (n = 34), hy gel is applied to the lm3 extraction socket, and in the hy + c test group (n = 34) hy gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. a more stable blood clot and thus improved wound healing including periodontal healing is expected through the use of hy.


Eligibility criteria:
inclusion criteria: 1. patients elder than 18 years; 2. uni- or bilateral vertical or mesioangular complete impaction of the lm3 classified to: 3. group ii- or iii- b or c according to pell-gregory (1933); 4. a distance ≥ 5 mm from the cej to marginal bone level at the distal aspect of the second molar. exclusion criteria: 1. patients with chronic diseases and/or 2. taking any medication, influencing hard and soft tissue healing; 3. acute pain/infection of the surgical region; 4. untreated periodontal disease; 5. patients smoking \> 10 cigarettes per day; 6. pregnancy; 7. history of hypersensitivity or allergy to hy; 8. absence of an adjacent second molar; 9. presence of caries or restoration on the distal aspect of the adjacent second molar; and 10. inability to attend the follow-up appointments.